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TAVR, AVR yield similar health improvements in high-risk patients
Patients at high surgical risk who undergo either self-expanding transcatheter aortic valve replacement or surgical aortic valve replacement experience similar significant improvements in health status, according to recent results.
Researchers used data from the CoreValve US Pivotal Trial to evaluate 709 patients with severe aortic stenosis at high surgical risk, defined as a 15% or higher risk for death within 30 days of surgery. Patients were randomly assigned 1:1 to treatment with TAVR or AVR, and stratified based on planned access site: iliofemoral or noniliofemoral. The researchers evaluated disease-specific and generic health status at baseline and at 1 month, 6 months and 1 year after enrollment using validated questionnaires. They also assessed the rates of acceptable and favorable outcomes post-TAVR using a composite outcome of mortality and quality of life.
Over the course of follow-up, the researchers observed significant improvements in both groups in disease-specific and general health status. At 1-month, a significant interaction was evident between treatment allocation and access site for several of the key health parameters: Among patients treated with iliofemoral access, TAVR was linked with greater early improvement in health status vs. AVR, as indicated by 1-month Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scores that were 16.7 points higher (95% CI, 12.-21.3; P < .001). However, no differences were observed at 6 months or at 1 year.
The patterns were similar for KCCQ subscales, the SF-12 physical and mental summary scores and the EQ-5D: better scores at 1 month for TAVR, but no differences between TAVR and AVR at 6 months and 1 year. Among patients in the non-iliofemoral access cohort, there were no differences in health status parameters between the groups, except for a trend toward benefit associated with TAVR on the SF-12 physical health scale at 1 month (P = .126).
“When integrating survival with quality of life, we found that patients treated with TAVR were more likely to have an acceptable outcome compared with patients undergoing AVR,” the researchers wrote. “We believe that use of these combined outcomes is particularly relevant in the elderly population of patients considering TAVR or AVR, as they best represent the overarching goals of treatment from a patient perspective.”
Disclosure: Please see the full study for a list of relevant financial disclosures.